Exposure-response relationship between work-related hand-arm vibration exposure and musculoskeletal disorders of the upper extremities: the German hand-arm vibration study.

Objective. To quantify the exposure-response relationship between hand-arm vibration exposure and the risk of musculoskeletal disorders of the upper extremities (UMSDs), a case-control study was carried out among workers in the construction, mining, metal and woodworking industries. Methods. In total, 209 male cases and 614 controls were recruited. Cases were newly reported patients with UMSDs. Controls were a random sample of persons with compensable occupational injuries. Standardized personal interviews were performed among cases and controls by well-trained safety engineers. In addition to leisure activities and comorbidities, work histories of all participants were collected in detail. To quantify hand-arm vibration exposures, a database of vibration measurements of over 700 power tools was used. This database allows the detailed quantification of vibration exposures over time. A dose-response relationship between hand-arm vibration exposure and UMSDs was quantified by conditional logistic regression analyses. Results and conclusions. After adjusting for relevant confounders, statistically significant exposure-response relationships between cumulative hand-arm vibration exposure and UMSDs were established. A cumulative hand-arm vibration exposure of Dhv (vibration total value in three measuring directions) = 142,300 (95% confidence interval [CI] [90,600-333,200]) m2/s4·day or Dhw (vibration value in the direction along the forearm) = 38,700 (95% CI [25,400-80,900]) m2/s4·day is associated with a doubled risk of UMSDs.

Validity of a German Comprehensive Psychosocial Screening Instrument based on the ESC Cardiovascular Prevention Guidelines.

Background: Following guidelines for cardiovascular disease prevention of the European Society for Cardiology (ESC), the current study validated the German Comprehensive Psychosocial Screening Instrument in participants who underwent coronary angiography. Methods: 314 participants (Mage = 69.7 ± 12.0; 69 % male) completed the German Comprehensive Psychosocial Screening Instrument and validated comparison scales to measure depression (PHQ-9), anxiety (GAD-7), Type D personality (DS14), work stress (ERI), family stress (SMSS), trauma (PC-PTSD), and anger and hostility (Z-scale of MMPI-2). Results: Confirmatory factor analysis (CFA) confirmed that the psychosocial risk factors were separate entities rather than a signs or symptoms of a single broad indication of distress (CFI = .872, RMSEA = .056, SRMR = .058). Intraclass coefficients (ICC), kappa and diagnostic accuracy indicators (receiver operator characteristic [ROC] curves, sensitivity, specificity, and the positive and negative predictive values [PPV; NPV]) indicated that most screener scales were sufficient to good. We also compared patients with established coronary heart disease (CHD; n = 213) to those with no current CHD (n = 100) and found overall similar results. Discussion: The German version of the Comprehensive Psychosocial Screening Instrument has an acceptable performance. Aside from minor improvements, the screening instrument could be implemented in the cardiological practice to screen patients on multidimensional psychosocial risk.

Outpatient parenteral antimicrobial therapy in Germany: a prospective cohort study protocol.

INTRODUCTION: Outpatient parenteral antimicrobial therapy (OPAT) means intravenous administration of antibiotics outside the hospital. The antibiotics are administered at the patient's home. The advantages are the shortening of the inpatient stay, which means that patients can remain in their familiar environment, the reduction of nosocomial infections as well as the reduction of hospital and therapy costs. Nevertheless, OPAT is rarely performed in Germany, despite its international application. Therefore, systematic data on OPAT are not available in Germany. The project objective is to investigate the medical care using OPAT under medical, epidemiological and economic aspects within the framework of the Cologne Network of Infectious Diseases. METHODS AND ANALYSIS: Observational study with mixed-methods approach, qualitative analysis to identify physician-side factors to assess the attitude of general practitioners in Cologne with regard to possible implementation barriers of an OPAT. Longitudinal analysis of an OPAT patient cohort with respect to clinical and patient-relevant outcomes using descriptive and conclusive statistics. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Review Board of the University of Cologne, Germany (19-1284-1). Written informed consent was obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences. TRIAL REGISTRATION NUMBER: NCT04002453.

Potential Delay of Diagnosing Infraorbital Skin Tumors Due to Coverage by Face Masks During the COVID-19 Pandemic: An Observational Study.

Aim: To assess the potential danger of belated diagnosis or underdiagnosis of cutaneous infraorbital pathologies that are partially or fully covered by face masks worn due to the COVID-19 pandemic. Methods: We evaluated data of 257 patients with infraorbital pathologies presenting at a large tertiary German university center between 04/2020 and 06/2021. This mono-centric, retrospective analysis included descriptive statistics and non-parametric tests. Results: Out of 257 cutaneous infraorbital pathologies, 32 (12.5%) were partially and 20 (7.8%) fully covered by the required face mask. Significantly more patients with lesions that were partially or fully covered came from a single household (p=0.003, Fisher's exact test) with 125 (48.6%) patients reportedly living alone. In patients with multiple periocular pathologies (n = 51, 19.8%), the risk of at least one periocular lesion being covered by the face mask was significantly elevated (p=0.009, Fisher's exact test). As expected, malignant tumors were significantly larger than benign pathologies (largest diameter, malignant median 9.0mm, range 1.3-34.0mm, mean 10.5mm, and benign median 3.0mm, range 1.0-7.0mm, mean 4.3mm, respectively; p<0.001, Mann-Whitney-U test) and patients presenting with malignant lesions were significantly older (median age 78.4, range 33-93, mean 73.7 years versus median age 57.9, range 18-90, mean 59.8 years, respectively; p<0.001, Mann-Whitney-U test). Additionally, in subgroup analysis, patients with malignant lesions coming from single households were significantly older (p=0.041, Mann-Whitney-U test). Conclusion: For adequate and timely treatment of infraorbital lesions, patients should be examined without their face mask. This is of utmost importance for the elderly (being at greater risk for malignant pathologies) and patients coming from single households. The presence of multiple pathologies must always be excluded. Trial Registration Number: Not applicable.

Association between Periodontal Treatment and Healthcare Costs in Patients with Coronary Heart Disease: A Cohort Study Based on German Claims Data.

There is empirical evidence of an association between periodontitis and coronary heart disease (CHD). However, it is uncertain whether periodontal treatment in CHD patients might lead to reduced healthcare costs. This study aims to assess the association between periodontal treatment and healthcare costs in newly diagnosed CHD patients. Data from 21,263 adults who were continuously insured between 2011 and 2016 and who were newly diagnosed with CHD in 2013 were selected from a German claims database. The study population was differentiated by the utilization of periodontal treatment. The average treatment effect (ATE) of periodontal treatment on healthcare costs (total, inpatient, outpatient, drugs) was investigated using weighted Poisson regression models conditional on covariates and is shown as a ratio (of geometric means). Periodontal treatment was documented for 4.7% of the persons in the study population. Newly diagnosed CHD patients showed an ATE of 0.98 for total healthcare cost (95% CI 0.90-1.06), 0.79 for inpatient costs (95% CI 0.61-1.04), and 0.95 for drug costs (95% CI 0.87-1.04). A statistically significant 7% increase in outpatient costs was shown (95% CI 1.01-1.13). Despite a lack of statistical significance in most cases, the study provides evidence of a meaningful decrease in inpatient costs after periodontal treatment. Further studies are needed.

Health-related quality of life after 50 years in individuals with thalidomide embryopathy: Evidence from a German cross-sectional survey.

BACKGROUND: As individuals with thalidomide embryopathy now reaching their 60's they undergo long-term sequelae of their prenatal damage and experience a wide range of secondary health problems, in particular chronic musculoskeletal pain, movement restrictions, and mental disorders. These health problems are having a negative impact on their life circumstances and their health-related quality of life (HRQOL). OBJECTIVE: The aim of this study was to determine the HRQOL in individuals with thalidomide embryopathy in comparison to individuals of the age-adjusted general population in Germany with and without chronic disease conditions (primary outcome). And, further explore the influence of impairment patterns, pain stage, and mental disorders on physical and mental dimensions of HRQOL (secondary outcome). METHODS: A cross-sectional survey of 202 individuals with thalidomide embryopathy from North Rhine-Westphalia/Germany was conducted, which gathered information about physical examinations including a standardized determination of the pain stage, a structured psychological interview, and the HRQOL. The final dataset was 186 cases for primary outcome. RESULTS: Individuals with thalidomide embryopathy (50.6 years, 55.9% females) show a significantly reduced physical HRQOL comparison to the age-adjusted German population with chronic diseases (physical component score; pcs: 33.4 vs. 45.3, p < .001). In addition, male individuals with thalidomide embryopathy show a significantly reduced mental HRQOL to their male counterparts in this comparison (mental component score; mcs: 45.0 vs. 50.0, p = .005). The subgroup analyses show that individuals with thalidomide embryopathy with quadruple impairment have a significantly lower physical HRQOL than those with hearing loss (pcs: 25.0 vs. 38.5; ci's not overlapping). Second, individuals with thalidomide embryopathy with severe compared to mild stages of pain have significantly poorer levels of physical and mental HRQOL (pcs: 25.8 vs. 37.7, ci not overlapping; mcs: 40.4 vs. 51.8, ci's not overlapping). And, individuals with thalidomide embryopathy without a mental disorder show a high mental HRQOL (mcs: 53.2), while in comparison to the total sample those with somatoform and personality disorders have a significantly reduced physical HRQOL (pcs: 27.5 and 24.8; both ci's not overlapping), and those with depressive disorders have a significant reduced mental HRQOL (mcs: 38.0 vs. 45.8, ci's not overlapping). CONCLUSIONS: A longitudinal decreasing HRQOL in individuals with thalidomide embryopathy is known, as well as high prevalence of mental disorders and chronic pain syndromes. This study shows a strong association between these two influencing factors and a poor HRQOL.

The regression discontinuity design: Methods and implementation with a worked example in health services research.

BACKGROUND: The randomized controlled trial (RCT) is the gold standard in evidence-based medicine. However, this design may not be appropriate in every setting, so other methods or designs such as the regression discontinuity design (RDD) are required. METHOD: The aim of this article is to introduce the RDD, summarise methodology in the context of health services research and present a worked example using the statistic software SPSS (Examples for R and Stata in the Appendix A). The mathematical notations of sharp and fuzzy RDD as well as their distinction are presented. Furthermore, examples from the literature and recent studies are highlighted, and both advantages and disadvantages of the design are discussed. APPLICATION: The RDD consists of four essential steps: 1. Determine feasibility; 2. Note possible treatment manipulation, 3. Check for the treatment effect, and 4. Fit the regression models to measure the treatment effect. CONCLUSION: The RDD comes as an alternative for studies in health service research where an RCT cannot be conducted, but a threshold-based comparison can be made.

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

Epidemiological characteristics and clinical course of eyelid squamous cell carcinoma patients from a large tertiary centre between 2009 and 2020.

BACKGROUND/AIMS: To assess epidemiological tumour features, risk factors, clinical management and outcome of eyelid squamous cell carcinoma (SCC) and changes thereof. Furthermore, we searched for validating predictors of the American Joint Committee on Cancer (AJCC) 8 classification system. METHODS: We evaluated data of 117 patients with histologically proven eyelid SCC at a large tertiary German university centre between January 2009 and March 2020. This retrospective, monocentric analysis included descriptive statistics and non-parametric tests (p<0.05). RESULTS: Histologically controlled excision and follow-up was performed in 88 (75.2%) patients. In the remaining patients with higher T-category, individual adjuvant therapy combinations were initiated. We found higher numbers of nodal metastasis and recurrence for male patients and higher T-category (p=0.035, p=0.008 and p=0.001, p<0.001). Recurrence rates proved higher for patients with multiple lesions (p=0.008). Disease-specific survival (DSS) was 95.7% at 2 and 94.9% at 5 years of follow-up. Six patients (5.1%) died from eyelid SCC with nodal metastasis and higher T-category being negative prognostic factors (p<0.001 and p=0.009). Mortality was associated with tumour location in the medial upper eyelid, nodal metastasis being more frequent (p=0.001 and p=0.009) and tumour of the lower eyelid alone as positive predictor (p=0.012). T category differed in 34 (29.1%) patients when comparing AJCC 7 and 8 (p<0.001). Changes in T category as per the AJCC 8 classification resulted in better prediction of DSS (p=0.024). CONCLUSION: Special attention should be paid to male patients, tumour location in the upper medial eyelid and lymph node diagnostics. Prediction of DSS proved superior as per the AJCC 8 staging system.

A Cross-Provider Healthcare Management Program for Musculoskeletal Disorders: Results of a Randomized Controlled Trial in 22 German Companies.

Musculoskeletal disorders (MSDs) are among the most common cause for reduced work capacity and sick leave. Workplace health promotion programs are often neither tailored to the workplace nor the individual needs of the employees. To counteract lacking intersectional care, this four-year randomized controlled trial (RCT) aimed to investigate the effects of modular coordinating case management (treatment group) compared to supported self-management (control group) on MSD specific sick leave days (routine data), workability (WAI), self-efficacy (self-efficacy scale), and pain (German pain questionnaire, GPQ). The study network comprised 22 companies, 15 company health insurance funds, and 12 pension funds in Germany. Overall, 852 participants (Module A/early intervention: n = 651, Module B/rehabilitation: n = 190, Module C/reintegration: n = 10) participated. Both groups achieved fewer sick leave days, higher workability, and less pain (p < 0.0001) at follow-up compared to baseline. At follow-up, the coordinating case management group showed fewer disability days (GPQ), lower disability scores (GPQ), and lower pain intensities (GPQ) than the supported self-management group (p < 0.05), but no superiority regarding MSD specific sick leave days, workability, nor self-efficacy. Module A showed more comprehensive differences. The accompanying process evaluation shows barriers and facilitators for the implementation of the program, especially in a RCT setting.

Progress feedback in children and adolescents with internalizing and externalizing symptoms in routine care (OPTIE study): study protocol of a randomized parallel-group trial.

BACKGROUND: Progress feedback provides therapists with progress notes on a regular basis through the continuous assessment of participants throughout their treatment (e.g., symptoms, therapeutic alliance). While for adults the evidence base has increased over the years, progress feedback in the therapy of children and adolescents has not been sufficiently investigated. This manuscript describes the trial protocol of the OPTIE study: a randomized trial that tests the efficacy of a progress feedback system in children and adolescents under conditions of routine care. METHODS: The study is based on a randomized parallel-group trial with two treatment groups (routine, feedback) at an outpatient unit of a university hospital. The target sample size is 439 families consisting of children and adolescents aged 6 to17 years old with internalizing and/or externalizing symptoms. Both the patients and the therapists are independently assigned to the treatment groups by stratified block randomization. In both treatment groups patients receive routine care behavioral therapy for a study-related 12 months; additionally, in the feedback group, a progress feedback system with three components is applied (monitoring, report, and supervision). For three informants (caregiver, child [≥ 11 years], therapist) surveys are conducted every 6 weeks (e.g., symptoms, goals, motivation). For both treatment groups, comparison data is collected at baseline and at six and 12 months after the beginning of the intervention (pre, inter, post), and includes five informants (blinded clinician, therapist, caregiver, child [≥ 11 years], teacher). DISCUSSION: The OPTIE study will contribute to the evidence base of progress feedback in children and adolescents and has the potential to uncover treatments' effects in the small to medium range. Noteworthy features are the inclusion of children younger than 10 years old and the consideration of a blinded clinician rating. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00016737 ( https://www.drks.de/DRKS00016737 ). Registered 17 September, 2019.

The effects of webcams on German neonatal intensive care units - study protocol of a randomised crossover trial (Neo-CamCare).

BACKGROUND: The separation of parents and their prematurely born children during care in a neonatal intensive care unit (NICU) can have far-reaching consequences for the well-being of the parents and also of the children. The aim of this study is to evaluate the use of webcams on NICUs and to conduct a systematic assessment of their possible effects on parents and clinical staff. In addition, it aims at determining the need for webcams  in German NICUs and to identify possible barriers and moderators. The development and evaluation of practical guidance for the use of webcams will enable the comprehensive education of clinical staff and parents and, as a result, is intended to mitigate any potential undesirable consequences. METHODS: The study will be based on a mixed methods approach including all groups concerned in the care. Qualitative data will be collected in interviews and focus groups and evaluated using content analysis. The collection of quantitative data will be based on written questionnaires and will aim to assess the status quo as regards the use of webcams on German NICUs and the effects on parents, physicians, and nursing staff. These effects will be assessed in a randomised cross-over design. Four NICUs will be involved in the study and, in total, the parents of 730 premature babies will be invited to take part in the study. The effects on the nursing staff, such as additional workload and interruptions in workflows, will be evaluated on the basis of observation data. DISCUSSION: This study will be the largest multicentre study known to us that systematically evaluates the use of webcams in neonatal intensive care units. The effects of the  implementation of webcams on both parents and care providers will be considered. The results provide evidence to decide whether to promote the use of webcams on NICUs or not and what to consider when implementing them. TRIAL REGISTRATION: The trial has been registered at the German Clinical Trial Register (DRKS). Number of registration: DRKS00017755 , date of registration: 25.09.2019.

[Chronic Pain in People Impaired by Thalidomide Embryopathy: An Explorative Analysis of Prevalence, Pain Parameters and Biopsychosocial Factors]. / Chronische Schmerzen bei Menschen mit Thalidomid-Embryopathie Eine explorative Analyse zu Prävalenz, schmerzbezogenen Merkmalen und biopsychosozialen Faktoren.

OBJECTIVE: The aim of the study was to show the frequency, localisation, intensity, quality and degree of chronic pain in people with thalidomide-induced congenital defects (thalidomide embryopathy) and to investigate the association with biopsychosocial factors more closely. METHODS: A group of 202 people from North Rhine-Westphalia with thalidomide embryopathy were studied for the first time both physically for the pattern of the original damage and also psychiatrically in a structured diagnostic interview (SCID I & SCID II). The results were combined with a standardized pain interview (MPSS) and questionnaires on further pain-related (SF-36, painDETECT) and sociodemographic variables and analysed. In the analysis 167 completed datasets were included. RESULTS: The prevalence of pain in the sample population was 94%. The majority (107, 54.0%) already showed an advanced stage of chronicity in the MPSS: 63 subjects with Stage II (37.7%) and 44 with Stage III (26.3%). In 74 subjects (44.3%) the PainDetect score showed a possible or neuropathic pain component. The factors that most reliably influenced the chronicity of pain proved to be hip pain (p<0.001) and also mental health disorders (p=0.001), above major depression (p<0.001) and also somatic symptom disorders and substance-related disorders (p=0.001 in each case). Social variables proved non-significant here (p=0.094 for living alone, p=0.122 for unemployment, p=0.167 for lack of college education), as did the care situation (p=0.191 for care dependency) and the underlying pattern of organ damage (p=0.229 for damage to hearing, p=0.764 for dysmelia). CONCLUSIONS: People with thalidomide defects frequently suffer from a separate pain disorder which can be seen as secondary thalidomide-induced damage and which requires specialized and personalized multimodal pain management.

Current patterns of practice in spinal fusion for chronic low back pain-results from a survey at the German Spine Societies' Annual Congress 2018.

BACKGROUND: There is debate regarding criteria to select patients for lumbar fusion surgery who have chronic low back pain (CLBP) and corresponding degenerative changes, but without nerve root compression or neurogenic claudication. The aim of this study was to compare patterns in current practice. METHOD: A total of 143 printed questionnaires containing 51 questions were distributed at the German Spine Societies' (DWG) annual congress, 6-8 December 2018. RESULTS: We received 127 (89%) surveys (64 orthopedic surgeons and 63 neurosurgeons). Excluding the 22% who do not perform lumbar fusion for CLBP, 41.4% reported performing 1-10 lumbar fusion procedures for patients with CLBP per year, 20.2% reported 11-20, 10.1% reported 21-30 and 17.2% reported performing more than 50. A total of 44.9% of surgeons reported treating patients for at least 6-12 months conservatively before considering surgery; 65.6% considered postoperative pain reduction of 50-70% a treatment success; 32.6% of respondents believe that <50% of patients showed good outcomes after fusion in CLBP and only 15.5% believed that 70% or more showed good outcomes. Orthopedic surgeons perform more lumbar fusion surgeries than neurosurgeons (p = 0.05), fuse more lumbar segments than neurosurgeons (p = 0.02) and are more likely to suggest that their patients with CLBP cease smoking preoperatively (p = 0.02). CONCLUSIONS: Despite discouraging evidence in the literature, the majority of respondents still perform fusion surgery in patients with CLBP. The use of preoperative diagnostics and tests vary widely among spine surgeons.

The impact of periodontal treatment on healthcare costs in newly diagnosed diabetes patients: Evidence from a German claims database.

AIMS: There is sufficient scientific evidence for the bidirectional association between periodontal diseases and diabetes. In this context, we hypothesized that periodontal treatment leads to lower healthcare costs in newly diagnosed diabetes patients by promoting a milder disease course. METHODS: A total of 23,771 persons were investigated who were continuously insured by German health insurances between 2011 and 2016, 18 years or older, and newly diagnosed with diabetes in 2013. The study population was divided into a periodontal treatment and control group (no periodontal treatment). The average treatment effect of a periodontal treatment on various types of healthcare costs (inpatient, outpatient, drug costs) was analyzed by a doubly robust method. RESULTS: Finally, 5.3% of the study population could be assigned to the treatment group. In newly diagnosed diabetes patients with periodontal treatment, a reduction in total healthcare costs (0.96, 95%CI 0.89; 1.04), inpatient costs (0.87, 95%CI 0.69; 1.08), diabetes-related drug costs (0.93, 95%CI 0.84; 1.03) and other drug costs (0.97, 95%CI 0.89; 1.05) could be shown compared to the control group. CONCLUSIONS: This study provides evidence that periodontal treatment for diabetes patients reduces healthcare costs. Fewer diabetes-specific complications and hospitalizations are expected.

Quality of life and mortality after surgical treatment for vertebral osteomyelitis (VO): a prospective study.

PURPOSE: Vertebral osteomyelitis (VO) has a high mortality and leads to chronic pain and functional disability. Surgical treatment is often necessary. To date, little is known about the consequences of surgery on patient outcome. The aim of this study was to determine the quality of life (QoL) and mortality rates of surgically treated VO patients for a period of 2 years. METHODS: Patients with VO undergoing surgical treatment in a tertiary referral hospital from 2008 to 2015 were included prospectively. Data were collected before (T0) as well as 1 year (T1) and 2 years (T2) post-surgery. Within the European Spine Tango registry, prospective patient and QoL data were collected using validated outcome scores: Oswestry Disability Index, Short Form 36/EuroQol, Visual Analog Scale, and Core Outcome Measures Index. RESULTS: From 195 patients surgically treated for VO, QoL data were available from 136 patients at T0, 100 patients at T1, and 82 patients at T2, respectively. The 1- and 2-year mortality rates were 20% and 23%. Mainly all QoL outcome scores showed significant improvement at T1 and did not change significantly from T1 to T2. CONCLUSION: Surgical treatment of VO patients leads to significantly improved QoL. Nevertheless, QoL levels were below those of the general population. Our results underscore that spine disability questionnaires measuring QoL are mandatory to demonstrate comprehensively the severity of this entity. Our study confirms a high mortality and points out the role of VO as a potentially life-threatening condition.

Screening for Predictive Parameters Requiring Psycho-Oncological Intervention via the National Comprehensive Cancer Network Distress Thermometer in the Follow-Up of Uveal Melanoma Patients.

AIM: To assess a profile of uveal melanoma patients at risk of requiring active psycho-oncological intervention by employing the National Comprehensive Cancer Network (NCCN) distress thermometer. METHODS: Multivariate correlation and multiple linear regression analysis of data collected retrospectively from 106 consecutive patients suffering from uveal melanoma. RESULTS: Distress levels correlated with practical (p = 0.01), emotional (p = 0.003) and physical problems (p = 0.001) as well as the total number of issues reported (p < 0.001; ANOVA, respectively). Emotional issues added up to 39% of influence on distress levels. Nervousness, worry and sadness as the most important emotional issues tested correlated significantly with anatomic stage, tumor T-category, metastatic status and time after primary diagnosis and were present more frequently in patients with higher distress levels (p < 0.001, p = 0.002, p = 0.004, respectively, Fisher's exact test). Pre-existing psycho-oncological support was more frequent in metastatic patients and patients with higher anatomic stage tumors (p = 0.008 and p = 0.003; Fisher's exact test). CONCLUSION: The distress thermometer proved to be useful for rapid assessment of patients requiring active intervention. A higher number of distress items recorded correlated with elevated distress levels. Emotional issues were responsible for the majority of problems. A typical patient profile at risk of developing distress requiring close attention of caregivers includes high anatomic stage, high T-category, presence of metastases and early follow-up. Correct diagnosis and interpretation of distress-levels should help improve the quality of life of uveal melanoma survivors. TRIAL REGISTRATION: Not applicable.

Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol.

INTRODUCTION: International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare. METHODS AND ANALYSIS: The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations. TRIAL REGISTRATION NUMBER: DRKS00015326; Pre-results.

Optimising the number of cores for magnetic resonance imaging-guided targeted and systematic transperineal prostate biopsy.

OBJECTIVES: To assess cancer detection rates of different target-dependent transperineal magnetic resonance (MR)/ultrasonography (US) fusion-guided biopsy templates with reduced number of systematic cores. PATIENTS AND METHODS: Single-centre outcome of transperineal MR/US fusion-guided biopsies of 487 men with a single target MR imaging (MRI) lesion, prospectively collected between 2012 and 2016. All men underwent transperineal targeted biopsy (TB) with two cores, followed by 18-24 systematic sector biopsies (SB) using the Ginsburg protocol. Gleason score ≥7 prostate cancer detection rates for two-core TB, four-core extended TB (eTB), 10- to 20-core saturation TB (sTB) including cores from sectors adjacent to the target, and 14 core ipsilateral TB (iTB) were compared to combined TB+SB. RESULTS: Cancer was detected in 345 men and Gleason score 7-10 cancer in 211 men. TB alone detected 67%, eTB 76%, sTB 91% and iTB 91% of these Gleason score 7-10 cancers. In the subgroup of 33 men (7% of cohort) with an anterior >0.5 mL highly suspicious MRI lesion and a prostate volume ≤45 mL, four-core eTB detected 31 of 32 cancers (97%) and all 26 Gleason score 7-10 cancers. CONCLUSION: sTB detected Gleason score 7-10 cancer in 25% more of the men than a two-core TB approach, and in almost as many men (91%) as the 20-26-core combined TB+SB, while needing only 10-20 cores. A four-core extended TB may suffice for large, highly suspicious anterior lesions in small or slightly enlarged prostates.